Wednesday, October 12, 2016
Independent Data Safety Monitoring Board (DSMB) Unanimously Recommends CardioCell’s Heart Failure Studies Continue
Phase IIa Clinical Trial Results Validate Safety and Potential Benefits of IV Administration of Stem Cells for Chronic Heart Failure IndicationsSubtitle
SAN DIEGO – Oct. 12, 2016 – CardioCell LLC, a global biotechnology company that uses allogeneic stem cells for cardiovascular indications, announces an independent data safety monitoring board (DSMB) concluded its review of the company-sponsored Phase IIa clinical trial results and votes unanimously to recommend studies continue. The trial, “Safety and Efficacy of Intravenous (IV) Infusion of Ischemia-Tolerant Allogeneic Mesenchymal Stem Cells (itMSCs) in Patients With Non-ischemic Cardiomyopathy” reported positive results in August.
Chaired by noted cardiologist Dr. Barry Greenberg, Distinguished Professor of Medicine and Advanced Heart Failure Treatment Program Director at the University of California San Diego Medical Center, the DSMB reviewed data on all “22 patients, including adverse events, serious adverse events, blood chemistries and hematology, electrocardiogram and pulmonary function testing.” He and the other participants — Dr. James C. Fang, Chief of the Division of Cardiovascular Medicine at the University of Utah School of Medicine and Director of the Cardiovascular Service Line at the University of Utah Health Care; Dr. Gregory Daniels, Associate Clinical Professor of Medicine, Division of Hematology-Oncology at the University of California San Diego Moores Cancer Center; and Ed Lombardi, Manager of Biostatistics at contract research organization (CRO) Agility Clinical Inc. — “voted unanimously to recommend that the study continue” and did not recommend “any change in the protocol or study operations.” Today’s conclusion of the DSMB review, which is required for multicenter and randomized Phase II clinical trials like CardioCell’s, verifies that the study’s stem cells and IV administration strategy are safe.
“With the DSMB’s validation of our Phase IIa safety data, CardioCell is accelerating efforts to initiate a larger, pivotal, multicenter study based on IV delivery of our itMSCs for both non-ischemic and ischemic cardiomyopathy,” says Sergey Sikora, CEO of CardioCell and co-author of the study. “In addition to the safety data, we are very encouraged by our clinical trial’s positive data on quality of life, and we look forward to exploring new possibilities in the pivotal trial.”
Only CardioCell’s therapies feature itMSCs, which are exclusively licensed from Stemedica. Unlike MSCs grown under normoxic conditions, bone-marrow-derived, allogeneic itMSCs are grown under hypoxic conditions. In vivo experiments demonstrate cells that are exposed to hypoxic conditions show greater homing and engraftment than cells grown under normoxic conditions. Compared to MSCs manufactured under normal oxygen condition, itMSCs secrete higher levels of growth factors and other important proteins associated with neoangiogenesis and healing.
About CardioCell LLC
Founded in San Diego, California, in 2013, CardioCell LLC is a global biotechnology company that explores therapeutic applications of unique, patented, ischemia-tolerant mesenchymal stem cells manufactured under cGMP conditions. CardioCell is a subsidiary of Stemedica Cell Technologies Inc., a global biotechnology company that manufactures adult allogeneic stem cells. The company’s technology is based on more than 30 years of research and clinical experience conducted by scientists and physicians in the United States, Europe and the former Soviet Union. CardioCell therapies offer a unique, proprietary technology based on the expansion of cells in constant hypoxia. The company has an exclusive, worldwide license from Stemedica to explore therapeutic indications for unmet cardiovascular needs, such as acute myocardial infarction, chronic heart failure and peripheral artery disease. For more information, visit www.stemcardiocell.com.
About Stemedica Cell Technologies Inc.
Stemedica Cell Technologies Inc. is a global biopharmaceutical company that manufactures best-in-class allogeneic adult stem cells and stem cell factors. The company is a government licensed manufacturer of cGMP, clinical-grade stem cells currently used in US-based clinical trials for acute myocardial infarction, chronic heart failure, cutaneous photoaging, ischemic stroke, Alzheimer’s disease and traumatic brain injury. Stemedica’s products are also used on a worldwide basis by research institutions and hospitals for pre-clinical and clinical (human) trials. Stemedica is currently developing additional clinical trials for other medical indications using adult, allogeneic stems cell under the auspices of the FDA and other international regulatory institutions. The company is headquartered in San Diego, California, and can be found online at www.stemedica.com.